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Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome

Recruitingn/aAges 18 Years - 99 YearsFemaleWalter Reed National Military Medical Center
NCT06729151 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Interstitial cystitis/bladder pain syndrome (IC/BPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC/BPS as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes". IC/BPS significantly impacts quality of life, with the individual domains of sexual function, anxiety and depression, sleep quality and work productivity being specifically affected. Significant sexual dysfunction in women with IC/BPS has been consistently demonstrated across multiple international studies, with a prevalence ranging from 68% to 91%. In fact, among all patients with lower urinary tract symptoms, patients with a diagnosis of IC/BPS had

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female 18 years of age and older * For bladder pain syndrome participants: O'Leary Sant score 13 or greater * For healthy controls: O'Leary Sant score 12 or less * DEERS eligible (care provided by military health care system) Exclusion Criteria: * Contraindications for bladder Botox * Current use of alternative treatment for bladder pain syndrome * Neurogenic bladder * Other urinary tract disease * Pelvic organ prolapse stage 3 or greater * Pregnancy or breastfeeding * Non-English speakers
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What it tests

  • Onabotulinum toxin A
  • Conservative management (dietary and behavioral)
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Where

1 site
Walter Reed National Military Medical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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